Optimally, a technology-based health care system that fully integrates the technical and social aspects of patient care and therapy should be able to flawlessly connect the client with care providers irrespective of separation distance or location of the participants. While clinicians will continue to treat patients in accordance with accepted modern medical practice, developments in communications technology are making it ever more possible to provide medical services in a manner independent of time and location.
The medical device industry produces a wide variety of electronic and mechanical devices for treating patient medical conditions. Depending upon the medical condition, medical devices can be surgically implanted or connected externally to the patient receiving treatment. Clinicians use medical devices alone or in combination with therapeutic substance therapies and surgery to treat patient medical conditions. For some medical conditions, medical devices provide the best, and sometimes the only, therapy to restore an individual to a more healthful condition and a fuller life. One type of medical device is an implantable therapeutic substance infusion device.
An implantable therapeutic substance infusion device is implanted by a clinician into a patient at a location appropriate for the therapy. Typically, a therapeutic substance infusion catheter is connected to the device outlet and implanted to infuse the therapeutic substance such as a drug or infusate at a programmed infusion rate and predetermined location to treat a condition such as pain, spasticity, cancer, and other medical conditions. Many therapeutic substance infusion devices are configured in such a way that the device can be replenished with therapeutic substance through a septum while the device is implanted, so the time the device can be implanted may not be limited by therapeutic substance capacity. An example of an implantable therapeutic substance infusion is shown in Medtronic, Inc. product brochure entitled “SynchroMed® Infusion System” (1995). The infusion device has a housing; a power source; a therapeutic substance reservoir configured for containing a therapeutic substance and being refilled with the therapeutic substance while implanted; a therapeutic substance pump fluidly coupled to the therapeutic substance reservoir, and electrically coupled to the power source; and, electronics electrically coupled to the power source and coupled to the therapeutic substance pump. The electronics include a processor; memory coupled to the processor; an infusion program residing in memory, the infusion program capable of being modified once the therapeutic substance infusion device is implanted; and, transceiver circuitry coupled to the processor for externally receiving and transmitting therapeutic substance infusion device information.
An implantable therapeutic substance delivery device, also known as a drug pump, can be used for a wide variety of therapies such as pain, spasticity, cancer, and many other medical conditions. An implantable therapeutic substance delivery device is typically implanted by a clinician, such as a surgeon, in a sterile surgical procedure performed under local, regional, or general anesthesia. The implantable therapeutic substance delivery device is generally implanted subcutaneously about 2.5 cm (1.0 inch) beneath the skin where there is sufficient subcutaneous tissue to support the implanted system. Once the therapeutic substance delivery device is implanted into the patient, the incision can be sutured closed and the therapeutic substance delivery device can begin operation.
The therapeutic substance delivery device operates to infuse a therapeutic substance at a programmed rate into a patient. The therapeutic substance is a product or substance intended to have a therapeutic effect such as pharmaceutical compositions, genetic materials, biologics, and other substances. Pharmaceutical compositions are chemical formulations intended to have a therapeutic effect such as intrathecal antispasmodics, pain medications, chemotherapeutic agents, and the like. Pharmaceutical compositions are often configured to function in an implanted environment with characteristics such as stability at body temperature to retain therapeutic qualities, concentration to reduce the frequency of replenishment, and the like. Genetic materials are substances intended to have a direct or indirect genetic therapeutic effect such as genetic vectors, genetic regulator elements, genetic structural elements, DNA, and the like. Biologics are substances that are living matter or derived from living matter intended to have a therapeutic effect such as stem cells, platelets, hormones, biologically produced chemicals, and the like. Other substances are substances intended to have a therapeutic effect yet are not easily classified such as saline solution, fluoroscopy agents, and the like.
The therapeutic substance can be replenished in some embodiments of the implanted therapeutic substance delivery device by inserting a non-coring needle connected to a syringe filled with therapeutic substance through the patient's skin into a septum on the therapeutic substance delivery device to fill the implanted device reservoir. If the therapeutic substance delivery device requires replacement due to conditions such as battery depletion or other conditions, an incision is made near the implanted therapeutic substance delivery device, and the old therapeutic substance delivery device is removed, also known as explanted. After the old therapeutic substance delivery device has been explanted, typically a new therapeutic substance delivery device is then implanted.
Prior art methods of clinical intrathecal therapy are generally limited to the implantable therapeutic substance infusion device's physical requirements. For example, if a physician needs to review the performance parameters of an implantable therapeutic substance infusion device in a patient, it is likely that the patient will have to go to the clinic. Further, if the medical conditions of a patient with an implantable therapeutic substance infusion device warrant a continuous monitoring or adjustment of the device, the patient would have to stay in a hospital indefinitely. Such a continued treatment plan poses both economic and social problems.
Currently, there is very little direct connectivity between the patient, the implantable drug pump manufacturer, the physician, the pharmacist, and the implantable device surgeon with the implantable drug pump. For instance, when the clinician implants a drug pump into a patient, the patient really has no other involvement with the implanted drug pump. Typically the patient merely conveys to the clinician their responses to their therapy during periodic medical appointments. Likewise, the clinician, implantable drug pump manufacturer, and pharmacist have no coordination with each other.
Presently, the clinician will receive the medical device and a manual of operation and installation containing generalized listings to assist the clinician in planning how to use the drug pump with a drug therapy. The listings are based upon an average of drug pump parameters and likely real-life scenarios which are made quite conservative to avoid the risk of failure of the drug pump while installed inside the patient. Therefore, the only way for a clinician to get a better understanding of the technical characteristics of the drug pump is reading the drug pump manual or a possible discussion with a drug pump technical representative.
The pharmacist's coordination with other drug pump stakeholders is limited as well. The pharmacist typically will receive a drug pump medication prescription by fax, mail, or delivery; then fill the prescription and deliver the medication to the clinician. Therefore, no interaction occurs between the pharmacist, clinician, drug pump manufacturer, and patient. This is a very compartmentalized way of performing intrathecal therapy with minimal information interchanged. Thus the capabilities of the implantable drug pump and the capabilities of the therapeutic substances are not optimized.
Electrically powered implanted therapeutic substance infusion devices can require replacement once implanted due to factors such as battery consumption, corrosion damage, and mechanical wear. Since replacement of the implanted device requires an invasive procedure of explanting the existing device and implanting a new device, it is desirable to only replace the infusion device when replacement is required. Replacement of previous implantable infusion devices was typically scheduled based upon a worst-case statically forecasted elective replacement period. The worst-case scenario typically resulting in the implanted infusion device being replaced several months or even years before the implanted infusion device required replacement. Some previous implantable pulse generators such as pacemakers have monitored a single sensed battery condition to estimate replacement time for the implanted device or battery such as shown in U.S. Pat. No. 6,167,309 “Method For Monitoring End Of Life For Battery” by Lyden (Dec. 26, 2000).
For the foregoing reasons, it would be desireable, in connection with the implantation of therapeutic substance infusion devices to provide a system by which the lifespan of the device could be predicted, thus increasing the infusion device's effective life, reducing the need for a clinician to perform static longevity forecasts for therapy changes, facilitate a broader range of possible elective replacement scheduling for the convenience of the patient and clinician, and many other improvements.
Dosage calculators in some form are currently available for clinicians to use. However, because present dosage calculation systems do not provide the patients, other clinicians, pharmacists and dispensaries, and drug pump manufactures with connectivity to each other. These devices operate with a minimum of real-world information from these valuable sources of pertinent information. Further, prior art dosage calculators do not provide the ability to view a patient's drug history, and intrathecal drug history, and assess drug dosage trends or perform a convenient detailed check of a patient's information such as drug allergies. Finally, the prior art devices do not take into account the detailed specification of the implanted drug pump when therapeutic substance infusion therapy, such as intrathecal therapy, is being prepared. Currently the clinician may have some very broad parameters of the pump. For example, the clinician might have the implantable pump's drug reservoir volume, or they might know the ranges in which the infusion rates operate. However, such general parameters yield a prediction of dosage and device lifespan, which could be improved upon.
The proliferation of patents with implantable drug pumps worldwide has made it desirable to provide remote services to the drug pumps and timely clinical care to the patient. Frequent use of programmer devices to communicate with implantable medical devices and provide various remote services, consistent with co-assigned patents, titled “System and Method for Transferring Information Relating to an Implantable Medical Device to a Remote Location,” U.S. Pat. No. 6,250,309; “Apparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,” U.S. Pat. No. 6,442,433; “Tactile Feedback for Indicating Validity of Communication Linik with an Implantable Medical Device,” U.S. Pat. No. 6,644,321; “Apparatus and Method for Automated Invoicing of Medical Device Systems,” U.S. Pat. No. 6,385,593; “Apparatus and Method for Remote Self-Identification of Components in Medical Device Systems,” U.S. Pat. No. 6,754,538; “Apparatus and Method to Automate Remote Software Updates of Medical Device Systems,” U.S. Pat. No. 6,363,282; “Method and Apparatus to Secure Data Transfer From Medical Device Systems,” U.S. Pat. No. 7,039,810; “Implantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,” U.S. Pat. No. 6,411,851; “Remote Delivery Of Software-Based Training For Implantable Medical Device Systems,” U.S. Pat. No. 6,386,882; “Apparatus and Method for Remote Therapy and Diagnosis in Medical Devices Via Interface Systems,” U.S. Pat. No. 6,418,346; “Virtual Remote Monitor, Alert, Diagnostics and Programming For Implantable Medical Device Systems” U.S. Pat. No. 6,497,655; “Implantable Therapeutic Substance Infusion Device with Active Longevity Projection” U.S. Pat. No. 7,001,359; “Implantable Therapeutic Substance Infusion Device Configuration System,” U.S. Pat. No. 7,072,725; all of which are hereby incorporated by reference herein in their entirety, has become an important aspect of patient care. Thus, in light of the disclosures herein, the present invention provides a vital system and method of dispensing/delivering efficient therapy and clinical care to the patient.